MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial

Bacterial Infections Clinical Trial

— MALDITOF  

Official title:

Assessing Time to Reporting and Clinical Management of Patients With Severe Bacterial and Fungal Infections Between Two Diagnostic Approaches: Matrix-assisted Laser Desorption Ionization-time of Flight Mass Spectrometry Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306330
• Other study ID #: 09HN
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: November 13, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of HealthVietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial Summary

MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an important new technology that is becoming routine in developed countries. It is currently unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.

Description:

When an eligible specimen from a patient shows pathogen growth, the pathogen identification will be randomized to either MaldiTof or routine diagnostics ('diagnostic pipelines'). Randomization to MaldiTof or routine diagnostics will be 1:1 with stratification by hospital and specimen type (blood vs. other). Isolates grown from all eligible specimens of the same patient will be assigned to the same diagnostic pipeline as the first randomized specimen of that patient.

Allocation to diagnostic arm will be assigned by a web based randomization program. When a pathogen is isolated from a positive eligible specimen, the laboratory technician will log onto the secure randomization program and enter the patient and specimen code. The random diagnostic pipeline allocation will then be generated, informed to the laboratory technician and logged in the study database. In the case of multiple specimens with pathogen growth for a single patient, the unique patient code will trigger the randomization program to generate the same diagnostic arm allocation as the previous sample(s).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria: Pathogen isolates from the following specimens: blood or diagnostic aspirates from normally sterile sites (including cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies).

Exclusion Criteria:

• Specimens negative for all pathogens

• Specimens from sputum, respiratory or non-surgical wound swabs, nails, mucosal or skin biopsies, urine, fluid from drains, skin swabs and any others not listed in the inclusion criteria.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Fungal Infections
• Infection
• Mycoses

Intervention

Device:
• Malditof
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.

Other:
• Routine clinical microbiology
Pathogens will be identified by the routine clinical microbiology of the hospital.

Locations

Country	Name	City	State
Vietnam	National Hospital for Tropical Diseases	Ha Noi
Vietnam	Hospital for Tropical Diseases	Ho CHi Minh City

Sponsors (3)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from first growth of an eligible specimen to optimal antibiotic treatment.		During hospital admission, estimated to be 0-48 hours	No
Other	Time from specimen collection of positive eligible specimen to optimal antibiotic treatment		During hospital admission, estimated to be 0-48 hours	No
Other	The time from first recognition of isolate growth to issue of pathogen identification report		Estimated 0-12 hours	No
Other	The time from specimen collection to issue of pathogen identification report		Estimated 24-48 hours	No
Other	Time from first specimen collection to discharge		Estimated to be 12 days	No
Other	Time from first pathogen identification to discharge		Estimated to be 10 days	No
Primary	Proportion of patients on optimal antibiotic treatment	Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen).	Within 24 hours of positive culture (first growth of an eligible specimen).	No
Secondary	The total duration of antibiotic treatment		During treatment course, estimated to be 7-10 days.	No
Secondary	The total number of antibiotic switches		During treatment course, estimated to be 7-10 days.	No
Secondary	Length of ICU stay		During ICU admission, estimated to be 7 days	No
Secondary	Length of hospital stay		During hospital admission, estimated to be 12 days	No
Secondary	Patient outcome: death, palliative discharge, survived with sequelae, recovered		On or before discharge, estimated to be at 12 days	No
Secondary	Costs of microbiological testing		On or before discharge, estimated to be at 12 days	No
Secondary	Treatment and hospital costs		On or before discharge, estimated to be at 12 days	No

External Links

•   Oxford University Clinical Research Unit Viet Nam